CN114831774A

CN114831774A - Intraocular lens design for improved stability

Info

Publication number: CN114831774A
Application number: CN202210486141.3A
Authority: CN
Inventors: 马利克·Y·卡霍克; 格伦·萨斯曼; 鲁道夫·F·扎克尔; 保罗·J·麦克莱恩; 罗伯特·E·阿特金森
Original assignee: ClarVista Medical Inc; University of Colorado
Current assignee: ClarVista Medical Inc; University of Colorado
Priority date: 2016-05-05
Filing date: 2017-05-04
Publication date: 2022-08-02
Also published as: US11045309B2; AU2017260081A1; EP3451970A1; US20210290374A1; US20170319332A1; JP2023175017A; CA3020911A1; JP2019514555A; AU2022203099B2; AU2017260081B2; CN109069267A; CN109069267B; JP7374167B2; JP7002471B2; AU2022203099A1; JP2022031502A; WO2017192855A1

Abstract

An intraocular lens (IOL) (300) improves lens stability by, for example, increasing the anterior-posterior stiffness of the IOL, increasing the anterior-posterior dimension of the IOL, and/or increasing the contact area with the capsular bag equator to resist movement of the IOL as the capsular bag collapses over time. These IOLs may be non-modular (single component) or modular (multiple components). In a modular embodiment, the IOL system may comprise an intraocular base and an optic which, when combined, form a modular IOL.

Description

Intraocular lens design for improved stability

(division of 201780027303.4)

Cross Reference to Related Applications

The benefit of priority of U.S. provisional patent application No. 62/332,163, entitled "INTRAOCULAR lens design FOR IMPROVED STABILITY (intrablock LENS DESIGNS FOR IMPROVED STABILITY)" filed 2016, 5.5.5.c. § 119(e), herein incorporated by reference in its entirety.

02 this application relates to U.S. patent application Ser. No. 15/342,806 entitled "Modular INTRAOCULAR lens design, tool AND method (MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS)" filed on 3.11.2016, U.S. patent application Ser. No. 15/218,658 entitled "Modular INTRAOCULAR lens design, tool AND method (MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS)" filed on 25.7.2016, U.S. patent application Ser. No. 15/176,582 entitled "Modular INTRAOCULAR lens design, tool AND method (MODULAR INTROCULAR LENS DESIGNS, TOOLS AND METHODS)" filed on 8.6.2016, U.S. patent application Ser. No. 15/150,360 (now U.S. patent No. 9,421,088) entitled "Modular INTRAOCULAR lens design, tool AND method (MODULAR LENS DESIGNS, TOOLS AND METHODS)" filed on 9.5.2016, AND U.S. patent application Ser. No. 15/150,360 entitled "FOR stability improving INTRAOCULAR lens design (FOOCRAROCULAR LENS DESIGNS (FOOCRAR) filed on 5.5.5.D United states provisional patent application No. 62/332,163 to IMPROVED STABILITY), "united states provisional patent application No. 62/318,272 entitled" MODULAR intraocular lens design, tool AND method (MODULAR intraocular LENS DESIGNS, TOOLS AND METHODS) "filed on 5.4.2016, united states patent application No. 15/054,915 entitled" MODULAR intraocular lens design, tool AND method (MODULAR intraocular LENS DESIGNS, TOOLS AND METHODS) "filed on 26.2.2016, united states provisional patent application No. 62/256,579 entitled" MODULAR intraocular lens design, tool AND method "(MODULAR intraocular LENS DESIGNS, TOOLS AND METHODS)" filed on 17.11.2015, united states provisional patent application No. 62/250,780 entitled "MODULAR intraocular lens design, tool AND method (MODULAR intraocular lens design, tool AND METHODS)" filed on 4.11.2015, united states provisional patent application No. 62/250,780 entitled "MODULAR intraocular lens design, tool AND method (MODULAR intraocular LENS DESIGNS, TOOLS AND METHODS)", AND, U.S. patent application No. 14/828,083 (now U.S. patent No. 9,364,316) entitled "MODULAR intraocular lens design, tool AND method" (MODULAR intraocular lens LENS DESIGNS, TOOLS AND METHODS) "filed on 8/17/2015, U.S. patent application No. 14/808,022 (now U.S. patent No. 9,387,069) entitled" MODULAR intraocular lens design AND method "(MODULAR intraocular lens LENS DESIGNS AND METHODS)" filed on 24/7/2015, U.S. provisional patent application No. 62/110,241 entitled "MODULAR intraocular lens design, tool AND method" (MODULAR intraocular lens LENS DESIGNS, TOOLS AND METHODS) "filed on 1/30/2015, U.S. patent application No. 14/610,360 AND method (MODULAR intraocular lens LENS DESIGNS, TOOLS METHODS)" filed on 1/30/2015, U.S. patent application No. 14/610,360 entitled "MODULAR intraocular lens design, tool AND method" (MODULAR intraocular lens design, tool AND method) "filed on 2/18/2014, AND, Us provisional patent application No. 61/941,167 to tool AND method (MODULAR INTRAOCULAR LENS DESIGNS, TOOLS AND METHODS), us patent application No. 13/969,115 to 2013, 8/16, entitled "MODULAR INTRAOCULAR lens design AND method (MODULAR INTRAOCULAR LENS DESIGNS & METHODS)" (now us patent No. 9,289,287), us patent application No. 13/937,761 to 2013, 7/9, entitled "MODULAR INTRAOCULAR lens design AND method (MODULAR INTRAOCULAR LENS DESIGNS AND METHODS)" (now us patent No. 9,125,736), us patent application No. 61/830,491 to 2013, 6/3, entitled "MODULAR INTRAOCULAR lens design AND method (MODULAR INTRAOCULAR LENS DESIGNS AND METHODS)", us provisional patent application No. 61/830,491 to tool AND method (MODULAR INTRAOCULAR lens design AND method (MODULAR 8658654 METHODS) ", us patent application No. 9,095,424 to 2013, 1/23, entitled" MODULAR INTRAOCULAR lens design AND method (MODULAR INTRAOCULAR lens 4624 & METHODS) "(now us patent application No. 9,095,424), United states provisional patent application No. 61/589,981 entitled "laser etching OF IN SITU INTRAOCULAR LENS AND sequential SECONDARY LENS IMPLANTATION (LASER ETCHING OF IN SITU INTRAOCULAR LENS AND supplementary LENS IMPLANTATION"), filed on 24/1/2012, AND united states provisional patent application No. 61/677,213 entitled "MODULAR INTRAOCULAR LENS design AND method" (MODULAR INTRAOCULAR LENS LENS DESIGNS & tools), filed on 30/7/2012, each OF which is incorporated herein by reference IN its entirety.

Technical Field

03 the present disclosure relates generally to intraocular lenses (IOLs). More particularly, the present disclosure relates to embodiments of IOL designs for improved stability in the capsular bag.

Background

The human eye 04 functions to provide vision by transmitting light through a transparent outer portion called the cornea and focusing the image by means of the crystalline lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye and the transparency of the cornea and lens.

05 when age or disease causes the lens to become less transparent (e.g., cloudy), vision deteriorates because of the diminished light that can be transmitted to the retina. This deficiency of the lens of the eye is medically known as a cataract. The accepted treatment for this condition is surgical removal of the lens from the capsular bag and placement of an intraocular lens (IOL) in the capsular bag. In the united states, the majority of cataractous lenses are removed by a surgical technique known as phacoemulsification. In this procedure, an opening is made in the anterior side of the capsular bag (capsulorhexis) and a fine phacoemulsification cutting tip is inserted into the diseased lens and vibrated ultrasonically. The vibrating cutting tip liquefies or emulsifies the lens so that it can be aspirated out of the capsular bag. The diseased lens, once removed, is replaced with an IOL.

06 after cataract surgery implantation of an IOL, the optical results may be less than ideal. For example, shortly after surgery, it may be determined that the refractive correction is wrong, resulting in a phenomenon sometimes referred to as "refractive error". This may be caused in part by the postoperative movement of the IOL within the capsular bag. Effective Lens Position (ELP), which is typically measured using scheimpflug photography (e.g., Pentacam, Oculus, germany), is a measure of the anterior-posterior distance from the anterior surface of the cornea to the anterior surface of the lens (also known as the anterior chamber depth or ACD). ELP can change significantly post-operatively, with a 1.0mm shift in ELP corresponding to a 3.0 diopter change in vision. Therefore, there is a need for a more postoperatively stable IOL to reduce variations in ELP and reduce refractive errors.

Disclosure of Invention

07 embodiments of the present disclosure provide IOLs that improve ELP stability by, for example, increasing the anterior-posterior stiffness of the IOL, increasing the anterior-posterior dimension of the IOL, and/or increasing the contact area with the equator of the capsular bag to resist movement of the IOL as the capsular bag collapses over time. These IOLs may be non-modular, unitary, or monolithic (i.e., a single component) or modular (multiple components). In a modular embodiment, the IOL system may comprise an intraocular base and an optic which, when combined, form a modular IOL.

08 in one embodiment, a modular IOL includes an annular base having two haptics extending radially outward. The base may define a central bore and an inner periphery, with the radially inwardly opening recess surrounding the inner periphery. The modular IOL system also includes a lens having an optic with a first tab and a second tab extending radially outward from the optic. The base and the lens may be assembled together with the first and second tabs of the lens disposed in the recess of the base. The base may have an anterior-posterior dimension greater than the lens to increase the anterior-posterior stiffness of the assembly. The base may also have an anterior-posterior dimension (i.e., between the leaflets of the capsular bag) that approximates the anterior-posterior dimension of the interior of the capsular bag for reducing anterior-posterior displacement in the capsular bag.

09 in another embodiment, a modular IOL comprises a base configured to receive a conventional lens. The base may be annular, having a central aperture, two haptics extending radially outward, and an internal protrusion for receiving a conventional lens having haptics. The base and lens may be assembled together with the periphery of the lens resting on the protrusions of the base and the haptics of the lens extending through slots in the base. Similar to other embodiments described herein, the base may have an anterior-posterior dimension that is larger than the lens in order to increase the anterior-posterior stiffness of the assembly. In addition, the base may also have an anterior-posterior dimension that approximates the anterior-posterior dimension of the interior of the capsular bag (i.e., between the leaflets of the capsular bag) for reducing anterior-posterior displacement in the capsular bag.

10 in yet another embodiment, a non-modular IOL includes an enlarged annular rim around the optic for increasing anterior-posterior stiffness. The enlarged annular rim may have an anterior-posterior dimension that approximates the anterior-posterior dimension of the interior of the capsular bag (i.e., between the leaflets of the capsular bag). A gap in the edge may be used to effect folding for delivery via a syringe. The rim may extend radially outward to form a buttress (buttons) between the optic and the haptics extending therefrom.

An IOL according to an embodiment of the present disclosure may be applied to a variety of IOL types, including fixed monofocal, multifocal, toric, accommodative, and combinations thereof. In addition, IOLs according to embodiments of the present disclosure may be used to treat, for example, cataract, large optical errors in near (myopic), distant (hyperopic) and astigmatic eyes, phakic ectopy, aphakic, pseudocrystalline, and nuclear sclerosis.

Various other aspects and advantages of embodiments of the present disclosure are described in the following detailed description and the accompanying drawings.

Drawings

Fig. 13 illustrates an exemplary embodiment of the present disclosure. The drawings are not necessarily to scale and may include similarly numbered elements and may include dimensions (in millimeters) and angles (in degrees) that are by way of example and are not necessarily limiting. In the drawings:

figure 1 is a schematic view of a human eye shown in cross-section;

FIG. 2 is a schematic view of the lens of a human eye shown in sagittal section;

16 fig. 3A is a perspective view of a modular IOL according to the present disclosure;

FIG. 3B is a graph of the results of a bench test comparing the performance of the modular IOL shown in FIG. 3A to commercially available IOLs;

FIGS. 4A-4D are perspective, top, cross-sectional and detailed views, respectively, of the base of the modular IOL shown in FIG. 3A;

FIGS. 5A-5E are perspective, top, cross-sectional and detailed views, respectively, of the lens of the modular IOL shown in FIG. 3A;

FIGS. 6A and 6B are perspective and cross-sectional views, respectively, of an alternative modular IOL according to the present disclosure;

figures 7A-7B are perspective views of an alternative base for use with a conventional IOL according to the present disclosure;

figures 8A-8C are perspective, cross-sectional and top views, respectively, of a non-modular IOL according to the present disclosure;

23 FIGS. 9A and 9B are perspective views of an alternative non-modular IOL according to the present disclosure;

FIGS. 10A and 10B are top and cross-sectional views, respectively, of another alternative non-modular IOL according to the present disclosure;

FIGS. 11A and 11B are top and cross-sectional views, respectively, of yet another alternative non-modular IOL according to the present disclosure;

12A and 12B are top and cross-sectional views, respectively, of another alternative non-modular IOL according to the present disclosure; and

fig. 13A-13C are perspective views of various alternative non-modular IOLs according to the present disclosure.

Detailed Description

28 reference will now be made in detail to examples of the present disclosure that are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. In the discussion that follows, relative terms such as "about," "substantially," "about," and the like are used to indicate a possible variation of the stated value, number, or other ± 10%, unless otherwise indicated.

29 referring to fig. 1, a human eye 10 is shown in cross-section. Eye 10 is depicted as an organ that reacts to light for a variety of purposes. The eye produces vision as a conscious sense organ. The rods and cones in the retina 24 produce conscious light perception and vision, including color discrimination and depth perception. In addition, the non-imaging light-sensitive ganglion cells of the human eye in the retina 24 receive light signals that affect pupil size adjustment, the regulation and suppression of the hormone melatonin, and the cyclic variation of the biological clock.

30 eyes 10 are not strictly spherical; but rather a fused two-piece unit. The more curved smaller anterior unit called the cornea 12 is connected to the larger unit called the sclera 14. The radius of the corneal section 12 is typically about 8mm (0.3 inch). The sclera 14 comprises the remaining five sixths; its radius is typically about 12 mm. The cornea 12 and sclera 14 are connected by a ring known as the limbus. Since the cornea 12 is transparent, the iris 16, the color of the eye and its black center, the pupil, can be seen, instead of the cornea 12. In order to see inside the eye 10, an ophthalmoscope is required, since the light rays are not reflected out. The fundus (the region opposite the pupil) containing the macula 28 shows a characteristic pale optic disc (papilla) through which blood vessels entering the eye pass, while the optic nerve fibers 18 exit the eyeball.

31 thus, the eye 10 is constructed of three layers of film that wrap around three transparent structures. The outermost layer consists of the cornea 12 and sclera 14. The middle layer is composed of the choroid 20, ciliary body 22, and iris 16. The innermost layer is the retina 24, which circulates from the blood vessels of the choroid 20 and the retinal blood vessels that are visible in the ophthalmoscope. Within these membranes are aqueous humor, vitreous body 26, and flexible lens 30. Aqueous humor is a transparent liquid contained in two areas: the anterior chamber between the cornea 12 and iris 16 and the exposed area of the lens 30; and the posterior chamber between the iris 16 and the lens 30. The lens 30 is suspended to the ciliary body 22 by zonules 32 (zonules fraxini) formed of thin, transparent fibers. The vitreous body 26 is a transparent gel much larger than the aqueous humor.

Lens 30 is a transparent, biconvex structure in the eye that, together with cornea 12, helps to refract light so that it is focused on retina 24. The lens 30 functions to change the focal length of the eye by changing its shape so that the eye can focus on objects at various distances, thereby allowing a sharp, true image of the object of interest to be formed on the retina 24. This adjustment of the lens 30 is called accommodation and is analogous to the focusing of a camera by movement of its lens.

The 33 lens has three main parts: lens capsule, lens epithelium, and lens fibers. The lens capsule forms the outermost layer of the lens, while the lens fibers form the majority of the interior of the lens. Lens epithelial cells located between the lens capsule and the outermost layer of lens fibers are predominantly present on the anterior side of the lens, but extend posteriorly to just beyond the equator.

The lens capsule is a smooth, transparent basement membrane that completely surrounds the lens. The capsule is elastic and consists of collagen. Collagen is synthesized by lens epithelial cells, and its main components are type IV collagen and sulfated glycosaminoglycans (GAGs). The capsule is very elastic and therefore gives the lens a more spheroidal shape when not under tension by the zonular fibers connecting the lens capsule to the ciliary body 22. The thickness of the bladder varies between about 2 and 28 microns, being thickest near the equator and thinnest near the posterior. The anterior curvature involved in the lens capsule may be greater than the posterior curvature of the lens.

35 may be used to treat various diseases and conditions of the lens 30 with IOLs. By way of example, and not necessarily by way of limitation, IOLs according to embodiments of the present disclosure may be used to treat cataract, large optical errors in near (myopic), far (hyperopic) and astigmatic eyes, phakic, aphakic, pseudocrystalline, and nuclear sclerosis. However, for purposes of description, IOL embodiments of the present disclosure are described with reference to cataracts that often occur in the elderly population.

36 as shown in fig. 2, the shape of lens 30 is generally symmetrical about a visual axis 37. However, the lens 30 is not symmetrical about the sagittal plane 39. Rather, the anterior side 33 of the lens 30 has a radius of curvature (R) _A ) Is larger than the rear side 35Radius of curvature (R) _P ). The equator diameter (D) is more anterior, with posterior lens thickness (T) _P ) Greater than the anterior lens thickness (T) _A )。

Data published by 37 Rosen (Rosen) et al (2006) indicates that: equator diameter D, posterior lens thickness T _P Anterior lens thickness T _A And front radius of curvature R _A Varying with age, and posterior radius of curvature R _P And the ratio T _A /T _P Remain unchanged. Rosen et al describe the following age-related equations for these parameters (all in mm) using a best-fit linear equation:

38D ═ 0.0138(± 0.002) × age +8.7(± 0.14) (R) ² ＝0.57；p<0.0001)；

39 T _A 0.0049(± 0.001) × age +1.65(± 0.075) (R) ² ＝0.45；p<0.0001)；

40 T _P 0.0074(± 0.002) × age +2.33(± 0.11) (R) ² ＝0.44；p<0.0001)；

41 R _A Age +7.5(± 1.13) (R) ═ 0.046(± 0.017) ² ＝0.27；p＝0.016)；

42 R _P -5.5(± 0.9); and is

43 T _A /T _P ＝0.70(±0.13)。

By way of example and not limitation, these data or other empirically measured data may be used to describe the shape and size of the lens for a particular age group, such as cataracts in elderly patients with an average age of 70 years. These data may be used to determine the space available for an intraocular implant to be placed in the capsular bag. For example, assume that an ocular implant (such as an IOL) will be centered in the equatorial plane with an anterior-posterior height "H" at a radial distance "X" from its center point. It is also assumed that it is desirable to have the anterior and posterior sides of the implant in contact with the wall of the capsular bag at a radial distance X in order to reduce migration of the implant. Mathematical modeling may be used to determine the height (H) of the lens capsule at any given radial distance (X) from the visual axis 37 along the equatorial plane.

The total height H of 45 is equal to the height of the front part (H) _A ) And a rear height (H) _P ) And (4) summing. Front height (H) _A ) Can be represented by equation H _A ＝Y-(R _A -T _A ) It is given. Although R is _A And T _A Is known empirically, but the distance (Y) from the equator plane may be given by the equation Y ═ (R) _A ² -X ² ) And ^ 0.5. Combining these equations, the front height may be represented by H _A ＝(R _A ² -X ² )^0.5-(R _A -T _A ) Given, and solved using empirical data. Height of rear part (H) _P ) The rear radius (R) may be used similarly _P ) And rear thickness (T) _P ) To calculate and use empirical data to solve. Height of the rear part (H) _P ) Height to front (H) _A ) The summation provides the total height (H) at a distance (X) from the visual axis. Thus, the desired height (H) of the intraocular implant at the radial distance X may be estimated such that the implant is in contact with the anterior and posterior walls of the capsular bag. Alternative mathematical models described in the literature may also be used.

46 the following detailed description describes various embodiments of modular and non-modular IOL systems. Features described with reference to any one embodiment may be applied to and incorporated into other embodiments.

47 referring to fig. 3A, base 400 and lens 500, when assembled, form an embodiment of modular IOL 300. A general description of modular IOL 300 follows, and further details are provided in U.S. provisional patent application No. 62/318,272, which is hereby incorporated by reference in its entirety.

48 referring to fig. 4A-4D, the base 400 is shown in greater detail. Fig. 4A is a perspective view, fig. 4B is a top view, fig. 4C is a sectional view taken along line a-a in fig. 4B, and fig. 4D is a detailed sectional view of circle C in fig. 4C. The dimensions (mm) are given as examples and are not necessarily limiting.

49 the base 400 includes an annular ring 402 defining a central aperture 404. A pair of haptics 406 extend radially outward from the annular ring 402. Annular ring 402 includes a lower edge 408, an upper edge 410, and an inward facing recess 412 into which lens 500 may be inserted to form modular IOL 300.

The upper edge 410 of the 50-ring loop 402 may include one or more notches 416 to provide intraoperative access for a probe (e.g., a Sinskey hook), which may allow for easier manipulation of the base 400. Haptics 406 may include holes 415 adjacent annular ring 402 for the same purpose as notches 416. A pair of square edges 417 may extend around the posterior periphery of annular ring 402 to help reduce cell proliferation (posterior capsule opacification or PCO) on lens 500.

51 with particular reference to fig. 4D, the deep portion of the pocket 412 may have a square profile defined by a horizontal rear surface 418, a horizontal front surface 420, and vertical side or outer surfaces 422. The recess may also include a flared forward surface 426 extending radially inward and forward outward from the horizontal forward surface 420 and a flared rearward surface 428 extending radially inward and rearward outward from the horizontal rearward surface 418. The inner diameter of trailing edge 408 may be less than the inner diameter of leading edge 410. With this arrangement, lens 500 can be placed through the circular opening defined by anterior edge 410 to fall or rest on the posterior edge, and the flared anterior wall 426 along with flared posterior wall 428 can act as a funnel to guide

tabs

504 and 506 of lens 500 into the deep portion of recess 412. When fully seated in the recess 412, the horizontal posterior wall 418, horizontal anterior wall 420, and vertical side walls 422 form a keyed geometry with the corresponding horizontal and vertical sides of the

tabs

504 and 506 to limit movement of the lens 500 relative to the base 400 in the anterior, posterior, and radial directions.

52 as best seen in fig. 4D, the base 400 may have H ═ H _A +H _P Wherein H is about 1mm, H _A About 0.5mm at a radial distance of about 3.2mm from the center point CP, and H _P About 0.5mm at a radial distance of about 2.65mm from the center point CP. However, as previously mentioned, the posterior thickness T of the native lens 30 _P Greater than the anterior thickness T of the native lens 30 _A . Thus, these relative dimensions can be adjusted. For example, H may be _P Greater than H _A Such that the sagittal midplane MP of base 400 is aligned with the equatorial plane (+/-0.5mm) of lens 30 when modular IOL 300 is implanted in the capsular bag. For example, the ratio H _A /H _P May be constant at about 0.7 (+ -0.3). Further, H can be selected such that when implanted in the capsular bag, the anterior-most portion of anterior edge 410 is in close proximity (within 0.5mm) to anterior side 33 of lens 30 and the posterior-most portion of posterior edge 408 is in close proximity (within 0.5mm) to posterior side 35 of lens 30. Thus, by way of example, and not limitation, e.g., H _A May be about 0.5mm to 1.0mm at a radial distance of about 2.75mm to 3.25mm from the center point CP, and H _P May be about 0.75mm to 1.5mm at a radial distance of 2.25mm to 2.50mm from the center point CP, e.g., to maintain a constant ratio H of about 0.7(± 0.3) _A /H _P 。

Referring to fig. 5A-5E, lens 500 is shown in greater detail at 53. Fig. 5A is a perspective view, fig. 5B is a top view, fig. 5C is a sectional view taken along line a-a in fig. 5B, fig. 5D is a detailed sectional view of circle B in fig. 5C, and fig. 5E is a detailed top view of circle C in fig. 5B. The dimensions (mm) are given as examples and are not necessarily limiting.

54 lens 500 may include an optic portion 502 and one or

more tabs

504 and 506. As shown, tab 504 is fixed, while tab 506 may be actuated. The securing tab 504 may include a through hole 208 such that a probe (e.g., a Sinskey hook) or similar device may be used to engage the hole 208 and manipulate the tab 504. The actuatable tabs 506 can be actuated between a compressed position for delivery into the holes 404 of the base 400 and an uncompressed extended position (as shown) for deployment into the recesses 412 of the base 400, thereby forming an interlocking connection between the base 400 and the lens 500. It is also contemplated that the actuatable tab 506 can be inserted into the recess 412 and can be actuated between a compressed position (to facilitate insertion of the fixation tab 504 into the recess 412) and an uncompressed extended position (to further insert the fixation tab 504 into the recess 412) to form an interlocking connection between the base 400 and the lens 500.

The 55 actuatable tab 506 may include two

members

510 and 512, each having one end connected to an edge of the optic 502 and the other end free, thus forming two cantilever springs. The edge 514 may extend around the perimeter of the optic 502, terminating the bounce of the

springs

510 and 512, thus allowing the

springs

510 and 512 to fully compress against the edge of the optic 502. The edge 514 of the lens 500 may have an outer diameter that is larger than the inner diameter of the posterior edge 408 of the base 400 such that the lens 500 does not fall into the opening 404 of the base 400 and such that the lens 500 is circumferentially supported around its circumference by the posterior edge 408 of the base 400. A gusset with guide holes 516 may be provided between the two

members

510 and 512 to facilitate manipulation by the probe. Similarly, guide holes 508 may be provided in the securing tabs 504 to provide access for probes (e.g., Sinskey hooks) or similar devices to manipulate the securing tabs 504 into the recesses 412 in the base 400. A notch 518 may be provided in the securing tab 504 to provide asymmetry as a visual indication that the front side is up (rather than down) when the notch is counterclockwise to the aperture 508. 56 as seen in fig. 5C, the anterior and posterior sides of optic 502 may have convex radii corresponding to the desired optical power (diopters) of the optic. As shown, the securing tabs 504 and the

spring tabs

510 and 512 can have flared cross-sections. More specifically, and as better seen in the detailed view shown in fig. 5D, the securing tabs 504 extend radially outward from the optic 502 from a thinner inner portion 504B to a flared thicker outer portion 504A. The aperture 508 may extend through the thinner inner portion 504B. The outermost profile of thicker portion 504A has a square profile with anterior horizontal sides, posterior horizontal sides, and lateral or outer vertical sides that are keyed to recesses 412 as previously described to minimize anterior-posterior and radial/lateral movement of lens 500 relative to base 400. The thicker portion 504A also improves engagement with the plunger of the injector, thereby mitigating clogging of the lens 500 in the injector. Thinner portion 504B also provides a forward and rearward offset from the surface defining recess 412 of base 400, thereby mitigating adhesion between lens 500 and base 400. As shown, the same splay configuration and associated advantages also apply to each

spring tab

510 and 512.

57 commercially available IOLs typically have a equator diameter (excluding haptics) of about 6mm, an anterior-posterior thickness of about 0.2mm at the 6mm diameter, and an anterior-posterior thickness of about 0.7mm at the center, thereby providing forA total volume of about 12mm 3. Lens 500 is of similar size but base 400 adds a much larger volume. The base 400 may have a equator diameter (excluding haptics) of about 7.8mm, an anterior-posterior thickness of about 1mm, providing a total volume of about 26 cubic millimeters [13.4mm ] when the lens is seated in the base ³ Base, 12.5mm ³ Optical device]. Thus, the combined size of the base 400 and lens 500 is much larger in volume than a commercially available conventional IOL. This relatively large volume is intended to fill the capsular bag more like a natural lens, thereby increasing the stability of modular IOL 300 and reducing post-operative migration due to capsular bag collapse around base 400. By comparison, the typical natural lens has a equator diameter of about 10.4mm, an anterior-posterior dimension of about 4.0mm, and a corresponding volume of about 180mm 3. Due to anatomical variations, the volume of the natural lens can be from 130mm ³ To 250mm ³ Within the range of (1). Thus, modular IOL 300 (base 400 plus lens 500) consumes greater than 10% (about 20% to 10.4%) of the capsular bag volume after the natural lens is removed, while conventional IOLs consume less than or equal to 10% (about 10% to 5%) of the capsular bag volume. In other words, modular IOL 300 consumes about twice the volume of the capsular bag as a conventional IOL.

58 also by comparison to conventional IOLs, modular IOL 300 provides a relatively large diameter and rigid platform by virtue of annular ring 402 of base 400, which resists deflection (i.e., increased stiffness in the sagittal plane, thereby improving anterior-posterior stability). Coupled with relatively long swept haptics 406, which provide a significant relative increase in surface contact with the capsular bag, modular IOL 300 provides excellent centering and stability within the capsular bag.

59 demonstrated resistance to deflection in a bench test comparing the performance of modular IOL 300 to a commercially available IOL (Alcon model SA60), the results of which are shown in FIG. 3B. In the experimental setup, the experimental IOL was placed in a 10mm inner diameter simulated capsular bag and the assembly was immersed in a warm bath. Various loads were applied to the middle of the test IOL while in the horizontal orientation, and the resulting downward displacement was measured. As can be seen from the results shown in fig. 3B, the commercially available IOL displaced approximately 5 times as much as modular IOL 300 and failed to support a load of 0.058 grams because the haptics were displaced away from the simulated capsular bag. This indicates a significant relative increase in stiffness of modular IOL 300 as compared to common commercially available IOLs.

60 this experimental setup can be compared with the equation F ═ k _eq Δ x describes a mechanical model of the center load on a beam with two simple supports to compare, where F — the applied force, k _eq Equivalent stiffness and Δ x displacement. The equivalent stiffness takes into account the cross-sectional moment of inertia of the beam and the material properties (young's modulus of elasticity) of the beam. However, since the IOL is made of plastic (rather than a resilient material such as metal), the equivalent stiffness will vary over the range of applied forces. In the described bench test, modular IOL 300 has an equivalent stiffness of about 0.5 to 2.0g/mm over an applied load range of 0.032 to 0.100g, while commercially available IOLs have an equivalent stiffness of about 0.15 to 0.20g/mm over an applied load range of 0.032 to 0.044 g.

61 in general, when base 400 and lens 500 are assembled together to form modular IOL 300, these features may be configured such that the midplane of optic 502 is parallel to the midplane of base 400, and the central (anterior-posterior) axis of optic 502 is coincident and collinear with the central (anterior-posterior) axis of base 400. Assuming that the natural lens capsule has anatomical symmetry and that the base 400 is centered in the lens capsule, this configuration substantially aligns the central axis of the optic 502 with the central (anterior-posterior) axis of the capsular bag, thereby centering the optic 502. However, there may be cases where the visual (foveal) axis is not aligned with the anatomy (pupillary axis), where the difference is called the kappa angle. In such cases, it may be desirable to offset the central axis of the optic 500 relative to the base 400, thereby providing decentration. This can be achieved, for example, by:

tabs

504 and 506, recess 412, and/or haptics 406 are configured such that the central (anterior-posterior) axis of optic 502 is laterally (nasally or temporarily) offset relative to the central (anterior-posterior) axis of base 400.

62 by way of example and not limitation, the sidewalls defining the recess 412 in the base 400 may be offset relative to the haptics 406 such that the central axis of the optic 502 is offset. Different offsets may be provided, for example 0.5mm to 2.0mm in increments of 0.5 mm. Angular orientation marks may be provided on the base 400 and lens 500 to indicate the direction of the offset (to the nose or temple). Similarly, the midplane of the assembled base 400 and optic 500 may be tilted relative to the equatorial plane of the natural capsular bag. To compensate for this tilt,

tabs

504 and 506, recesses 412, and/or haptics 406 may be configured such that the midplane of optic 502 is inversely tilted, for example.

63, including the alternative embodiments described herein, the base 400 and lens 500 may be formed by cryogenic processing and polishing of hydrophobic acrylic materials. Alternatively, the base 400 may be manufactured by forming two (front and rear) components and bonding them together. For example, the two components may be low temperature processed hydrophilic acrylic joined together by a uv curable adhesive. Alternatively, the two components may be formed of different materials that are adhesively joined together. For example, the anterior component may be formed of a hydrophilic acrylic that does not adhere to ocular tissue, while the posterior component may be formed of a hydrophobic acrylic that adheres to ocular tissue.

64 as another alternative, the base 400 may be manufactured by low temperature machining the first component and overmolding the second component. The first component may include geometric features that become interlocked when overmolded, thereby reducing the need to use an adhesive to connect the components. For example, the base 400 may be manufactured by: low temperature processing of hydrophilic acrylic to form a back component, and overmolding of a front component of moldable material such as silicone.

65 while the hydrophobic acrylic makes the base 400 and lens 500 visible using Optical Coherence Tomography (OCT), it may be desirable to include materials that enhance OCT visualization. Exemplary "OCT-friendly" materials include, but are not limited to, polyvinyl chloride, glycol-modified poly (ethylene terephthalate) (PET-G), poly (methyl methacrylate) (PMMA), and polyphenylsulfones, such as the polyphenylsulfone sold under the trade name RADELTM, as described in U.S. patent application publication No. 2013/0296694 to Ehlers et al, which is incorporated herein by reference. Such OCT friendly materials may be applied to or incorporated into a portion of the base 400 or lens 500.

66 by way of example, concentric rings of OCT friendly material may be applied to each of the lower edge 408 and the upper edge 410. The rings may have different diameters to help detect tilting of the base. Also by way of example, an OCT friendly material may be applied to tab 504/506 of lens 500. This can help determine whether the base 400 and lens 500 are properly assembled in the eye. Dots of OCT friendly material can be applied to portions of the base 400 that are aligned with corresponding dots of OCT friendly material on the optics 500 to indicate correct assembly in the eye.

67 as an alternative to a solid material, the base 400 and lens 500 can be made of a hollow material that can then be inflated in the eye. In such an arrangement, the base 400 and lens 500 may be made of, for example, molded silicone and inflated with a liquid such as saline, silicone gel, or the like using an injector and a needle. After implantation in the eye, the needles may pierce the walls of base 400 and lens 500 to inflate the components. After the needle is removed, the material can seal itself. As an alternative to a hollow material, the base 400 and lens 500 may be formed from a sponge-like material, such as a silicone hydrogel that expands when hydrated. Both methods may allow the size of the corneal incision to be smaller because the base 400 and lens 500 are delivered in an uninflated or uninflated state and then inflated or expanded once inside the eye.

68 in general, modular IOL 300, including assembled base 400 and lens 500 (including the alternative embodiments described herein), allows for intraoperative or postoperative adjustment or replacement of lens 500 while leaving base 400 in place. Examples of situations where such may be desirable include, but are not limited to: replacing the lens 500 to correct for sub-optimal refractive outcomes detected during surgery; replacing the lens 500 to correct the less than ideal refractive outcome (residual refractive error) detected post-operatively; rotationally adjusting the lens 500 relative to the base 400 to fine tune the toric correction; laterally adjusting the lens 500 relative to the base 400 to align the optics with the true optical axis (which may not be the center of the capsular bag); and replacing the lens 500 to address different optical needs or desires of the patient over a longer period of time. Examples of the latter case include, but are not limited to: adult or pediatric IOL patients whose original optical correction needs to be changed as he/she grows; patients who wish to upgrade from monofocal IOLs to advanced IOLs (toric, multifocal, accommodating or other future lens technologies); patients who are not satisfied with advanced IOLs and who want to degrade to monofocal IOLs; and patients who develop medical conditions to which IOLs or certain types of IOLs are contraindicated.

69 referring to fig. 6A and 6B, an alternative modular IOL 330 is shown in perspective and cross-sectional views, respectively. The alternative modular IOL 330 may include an alternative base 600 and a lens 500 as described above. As will be understood from the following description, the alternative base 600 may be similar to the base 400 except for the front edge 610 and the rear edge 608, the description of which is incorporated herein by reference. The alternative base 600 includes an annular ring defining a central aperture. A pair of haptics 606 extend radially outward from the annular ring. The annular ring includes a lower edge 608, an upper edge 610, and an inwardly facing recess 612 into which the lens 500 may be inserted to form the modular IOL 330.

70 with particular reference to fig. 6B, the lower edge 608 and the upper edge 610 may have relatively enlarged heights and may be angled radially inward to form a funnel leading to a recess 612. With this arrangement, actuatable tabs 506 of the lens can be compressed and the lens 500 can be placed through the circular opening defined by the anterior edge 610, wherein the funnel shape of the anterior edge 610 guides the

tabs

504 and 506 into the recess 612 of the base 600 to form a keyed geometry to limit movement of the lens 500 relative to the base 600 in the anterior, posterior, and radial directions. The funnel shape of the posterior edge 608 prevents the lens 500 from falling back during insertion of the lens 500 into the base 600.

71 by way of example, and not necessarily by way of limitation, the base 600 may have the dimensions shown. As best seen in fig. 6B, edges 608 and 610 of base 400 may have a combined anterior-posterior height that is 2.0 to 3.0 (or more) times the maximum thickness of optic 502 of lens 500. For example, the combined height of

edges

608 and 610 may be about 3mm at a radial distance of about 2.9mm from the center point. As previously described, the height of the posterior edge 608 can be made greater than the height of the anterior edge 610 such that the sagittal midplane of the base 600 is aligned with the equatorial plane of the lens 30 (+/-0.5mm) when the modular IOL 330 is implanted in the capsular bag. For example, the height ratio of the leading edge 610 to the trailing edge 608 may remain constant at a value less than 1.0, such as about 0.7(± 0.3). As shown, the combined height of anterior edge 610 and posterior edge 608 is selected such that when implanted in the capsular bag, the anterior-most portion of anterior edge 610 is in close proximity (within 0.5mm) to or pushes against anterior side 33 of lens 30 and the posterior-most portion of posterior edge 608 is in close proximity (within 0.5mm) to or pushes against posterior side 35 of lens 30.

72 referring to fig. 7A and 7B, an alternative base 700 is shown in perspective view for use with a conventional IOL100, wherein fig. 7A shows the base 700 in isolation and fig. 7B shows the base 700 and conventional IOL100 in combination assembled to form a modular IOL 360. The alternative base 700 is similar to the base 400 previously described, except for the inverted T-shaped slot 730, and the description of similar aspects and advantages are incorporated herein by reference.

73 the base 700 includes an annular ring 702 defining a central aperture 704. A pair of haptics 706 extend radially outward from the annular ring 702. Annular ring 702 includes a lower edge 708, an upper edge 710, and an inward facing recess 712 into which conventional IOL100 may be inserted to form modular IOL 360. The upper edge 710 of the annular ring 702 may include one or more notches 716 to provide access for a probe (e.g., a Sinskey hook) during surgery, which may make it easier to manipulate the base 700. The haptics 706 may include holes 715 adjacent the annular ring 702 for the same purpose as the notches 716.

Annular ring 702 may include a pair of inverted T-shaped slots 730 to receive haptics 106 diametrically opposed from conventional IOL 100. When haptics 106 of conventional IOL100 are placed in slots 730, the posterior side of optic portion 102 of conventional IOL100 may rest on the anterior surface of posterior edge 708. The posterior portion of slot 730 may have a greater width than its anterior portion to accommodate the angulation of haptics 106 and lock the IOL100 to base upon rotation of the IOL relative to base 700. The addition of the base 700 increases the anterior-posterior stiffness and height of the conventional IOL100, thereby improving its stability.

75 referring to fig. 8A-8C, a perspective view, a cross-sectional view, and a top view, respectively, of a non-modular IOL 800 is schematically illustrated. The non-modular IOL 800 combines several of the stability advantages previously described, but employs a non-modular construction. For example, IOL 800 includes an optical portion 802 that may be monofocal (fixed focal length), adaptive (variable focal length), toric, multifocal, or extended depth of focus mode. IOL 800 also includes two or more haptics 806 extending radially outward from the periphery of optical portion 802. Each haptic includes a posterior flange 808 and an anterior flange 810 extending and unfurled radially inward from the outer edge 809 in outward posterior and outward anterior directions, respectively. Each haptic 806 includes a connecting arm 812 that connects the outer edge 809 to the periphery of the optic 802. Each connecting arm 812 may include a window 814 to increase flexibility. The rear flange 808 and the front flange 810 are configured to compress relative to each other in a front-to-rear direction, acting like a cantilevered leaf spring around the outer edge 809.

76 with particular reference to fig. 8B, which is a cross-sectional view taken along line B-B in fig. 8A, it will be appreciated that the posterior flange 808 is sized and configured differently than the anterior flange 810 so as to conform to the shape of the capsular bag. As previously mentioned, the posterior thickness of the native lens is greater than the anterior thickness of the native lens. In order to conform the anterior flange 810 to the anterior side 33 of the lens capsule and the posterior flange 808 to the posterior side 35 of the lens capsule, the anterior flange 810 may have an anterior height H _A And an arc length, the front height and arc length being less than the rear height H of the rear flange 808 _P And arc length. For example, H may be _P Greater than H _A Such that the sagittal midplane MP of the base 800 is aligned with the lens capsule equatorial plane (+/-0.5mm) when the IOL 800 is implanted in the capsular bag. For example, the ratio H _A /H _P Can be largeAnd about 0.7 (+ -0.3) is unchanged.

77 with specific reference to fig. 8B and 8C, the radial lengths (in the sagittal plane) of the posterior and

anterior flanges

808, 810 may be selected such that the innermost edge does not interfere with the field of view through the optic 802. In other words, the posterior flange 808 and anterior flange 810 may extend radially inward from the outer edge 809 to the outer diameter of the optic portion 802, wherein the inner edges of the posterior flange 808 and anterior flange 810 form an arc that conforms to the outer diameter of the optic 802. The outer edge 809 may also form an arc in which the haptics 806 conform to the rounded shape of the equator of the natural lens capsule. By way of example, but not necessarily by way of limitation, the arcuate shape of haptics 806 may extend 60 ° to 90 °, 90 ° to 120 °, or 120 ° to 150 ° around the circumference of optic 802. The greater the arc length of the haptics, the greater the contact area with the equator of the natural lens capsule, the greater the stability of the IOL 800 in the capsular bag, but this must be balanced against the use of an injector to deliver the IOL 800 through a small incision.

78 referring to FIGS. 9A and 9B, alternative

non-modular IOLs

900 and 950 are shown in perspective view, respectively.

IOLs

900 and 950 are similar to IOL 800 described above in that the haptics include unfurled flanges for improved stability; descriptions of similar aspects and advantages are incorporated herein by reference.

79 with particular reference to FIG. 9A, the IOL 900 includes an optical portion 902 that may be monofocal (fixed focal length), adaptive (variable focal length), toric, multifocal, or extended depth of focus modes. IOL 900 also includes two or more haptics 906 extending radially outward from the periphery of optical portion 902. Each haptic 906 includes a posterior flange 908 and an anterior flange 910 that extend and unfurl radially inward in outward-posterior and outward-anterior directions, respectively, from an outer edge 909. Each haptic 906 includes a pair of linkage arms 912 that connect an outer edge 909 to the periphery of the optic 902. Each pair of connecting arms 912 may include a window 914 to increase flexibility. The rear flange 908 and the front flange 910 are configured to compress relative to each other in a front-to-rear direction, acting like a cantilevered leaf spring around an outer edge 909. The

flanges

908 and 910 of the IOL 900 have a smaller radial length (in the sagittal plane) extending from the outer edge 909 toward the optic 902 as compared to the IOL 800. In addition, a gap 911 is provided between the attachment arm 912 and the

flanges

908 and 910 along the inner connection with the outer edge 909 to provide space for the

flanges

908 and 910 to compress and fold down toward the optic 902. The gap 911 allows the connection between the outer edge 909 and the

flanges

908 and 910 to act as a resilient hinge and allows the

flanges

908 and 910 to better conform to the interior of a wall of a capsule that may vary in size and dimension.

80 with reference to fig. 9B, IOL 950 is similar to IOL 900, and descriptions of similar aspects and advantages are incorporated herein by reference. IOL 950 includes one or more haptics 906 that include curved arms 916 extending from the periphery of optic 902 (instead of connecting arms 912) to form outer edges 909 from which

flanges

908 and 910 extend. As in the previous embodiment, a gap 911 is provided to enhance the flexibility of the

flanges

908 and 910 relative to the curvilinear arm 916 along the outer edge 909 so that the connection between them acts as a resilient hinge.

81 referring to fig. 10A and 10B, an alternative non-modular IOL1000 is schematically illustrated. Fig. 10A is a top view of IOL1000, and fig. 10B is a cross-sectional view taken along line B-B in fig. 10A. For example, IOL1000 includes an optical portion 1002 that may be monofocal (fixed focal length), adaptive (variable focal length), toric, multifocal, or extended depth of focus modes. IOL1000 also includes a pair of haptics 1006 extending outwardly from optic portion 1002. A pair of gussets 1004 connect haptics 1006 to optic portion 1002. Whereas conventional IOLs provide haptics extending from the optic portion, IOL1000 utilizes gusset 1004 to push the attachment locations of haptics 1006 radially outward, thereby relatively increasing the anterior-posterior stiffness of the IOL in the sagittal plane. IOL1000 also includes a posteriorly extending ridge 1008 around the periphery of optic 1002 and the periphery of gusset 1004, excluding haptics 1006 and the junction of haptics 1006 with gusset 1004. Ridge 1008 increases the cross-sectional moment of inertia in the sagittal plane of IOL1000, thereby increasing its stiffness and stability without affecting the flexibility of haptic 1006. As seen in cross-section, ridge 1008 may have inner rounded corners and outer squared edges, as shown, to inhibit cell proliferation on optical portion 1002. By way of example, but not necessarily by way of limitation, the haptics may have an outer extent of 13mm (haptic tip to haptic tip), the optic may have a diameter of 5mm to 6mm, and the gusset 1004 may have an average sagittal width of 1mm to 2 mm. Thus, for a 5.0mm diameter optic 1002, haptics 1006 may be attached to gussets 1004 at a diameter of 7.0mm to 9.0 mm.

82 referring to fig. 11A and 11B, another alternative non-modular IOL 1100 is schematically illustrated. Fig. 11A is a top view of IOL 1100, and fig. 11B is a perspective cross-sectional view taken along line B-B in fig. 11A. As will be understood from the following description, IOL 1100 may be similar to IOL1000 except with respect to ridge 1108, the description of which is incorporated herein by reference. For example, IOL 1100 includes an optical portion 1102 that may be monofocal (fixed focal length), accommodative (variable focal length), toric, multifocal, or extended depth of focus mode. IOL 1102 also includes a pair of haptics 1106 extending outwardly from optic portion 1102. A pair of gussets 1104 connect haptic 1006 to optical portion 1102. Whereas conventional IOLs provide haptics extending from the optic portion, IOL 1100 utilizes gusset 1104 to push the attachment locations of haptics 1106 radially outward, thereby relatively increasing the anterior-posterior stiffness of the IOL in the sagittal plane. IOL 1100 also includes a ridge 1108 that extends around the periphery of optic 1102 and extends in the anterior and posterior directions. Ridge 1108 increases the cross-sectional moment of inertia in the sagittal plane of IOL 1100, thereby increasing its stiffness and stability without affecting the flexibility of gusset 1104 or haptics 1106. As seen in cross-section, the ridges 1108 may be rounded in an oval shape.

83 referring to fig. 12A and 12B, yet another alternative non-modular IOL1200 is schematically illustrated. Fig. 12A is a top view of IOL1200, and fig. 12B is a cross-sectional view taken along line B-B in fig. 12A. As will be understood from the following description, the IOL1200 may be similar to IOL1000 except with respect to a gusset or support portion 1204 and one or more ridges 1208, the description of which is incorporated herein by reference.

84 for example, IOL1200 includes an optic portion 1202 that may be monofocal (fixed focal length), adaptive (variable focal length), toric, multifocal, or extended depth of focus modes. IOL1200 also includes a pair of haptics 1206 extending outwardly from optic portion 1202. Haptic 1204 extends around the periphery of optical portion 1220 and connects haptic 1206 to optical portion 1202. Whereas conventional IOLs provide haptics extending from the optic portion, IOL1200 utilizes haptic portions 1204 to push the attachment locations of haptics 1206 radially outward, thereby relatively increasing the anterior-posterior stiffness of IOL1200 in the sagittal plane.

85 the support portion 1204 may surround the optic 1202. For example, support portion 1204 may extend concentrically a full 360 ° around the radially outer periphery of optic 1202. In one example, support portion 1204 can include an annular plate that forms a band around optic 1202. The plate may have a substantially constant width between its inner and outer circumferences.

The 86 support portion 1204 may include a forward-facing surface 1204a and a rearward-facing surface 1204 b. At least one of a forward-facing surface 1204a and a rearward-facing surface 1204b of support portion 1204 may extend substantially perpendicular to an optical axis 1202a of optical device 1202. The optical device 1202 may have a curved forward-facing surface 1202b and/or a curved rearward-facing surface 1202 c. Annular concave region 1203 may be formed on the anterior and/or posterior sides of IOL1200 where support portion 1204 meets optic 1202 because an anterior-facing surface 1204a of support portion 1204 forms an angle with anterior-facing surface 1202b of optic 1202 and/or a posterior-facing surface 1204b of support portion 1204 forms an angle with posterior-facing surface 1202c of optic 1202.

87 the thickness of support portion 1204 measured between forward-facing surface 1204a and rearward-facing surface 1204b of support portion 1204 may be substantially equal to the thickness of the radially outer periphery of optic 1202 (measured between the periphery of forward-facing surface 1202b and rearward-facing surface 1202c of optic 1202). Additionally or alternatively, the thickness of the support portion 1204 may be substantially equal to the thickness of the haptic 1206 (measured between a forward facing surface 1206a and a rearward facing surface 1206b of the haptic 1206).

88 the IOL1200 may also include one or more protrusions or ridges 1208. One or more ridges 1208 may extend around, along, and/or around one or more portions of the radially outer periphery of haptic 1206 and support portion 1204. In one example, the one or more ridges 1208 can include one or more ridges extending from the forward-facing surface 1204a of the support portion 1204 in a forward direction. For example, the one or more forwardly extending ridges may include ridge 1208a and/or ridge 1208 b. Additionally or alternatively, the one or more ridges 1208 may include one or more ridges extending in a rearward direction from the rearward-facing surface 1204a of the support portion 1204 b. For example, the one or more rearwardly extending ridges may include ridge 1208c and/or ridge 1208 d. One or more ridges 1208 may increase the cross-sectional moment of inertia of the entire IOL1200 in the sagittal plane, including the optic 1202, support portion 1204, and haptics 1206, thereby increasing its stiffness and stability. While fig. 12A and 12B show a pair of forwardly extending ridges 1208a and 1208B and a pair of rearwardly extending

ridges

1208c and 1208d, it is contemplated that fewer ridges can be employed. For example, IOL1200 may include only forwardly extending

ridges

1208a and 1208b, or only rearwardly extending

ridges

1208c and 1208 d.

89 as seen in cross-section in fig. 12B, one or more ridges 1208 may have a square profile to reduce cell proliferation on the optical portion 1202. For example, one or more of the

ridges

1208a, 1208b, 1208c, and 1208d can include opposing

surfaces

1208e and 1208f that extend substantially perpendicular to the forward-facing surface 1204a and/or the rearward-facing surface 1204b of the support portion 1204. Additionally or alternatively, the opposing

surfaces

1208e and 1208f can extend substantially parallel to one another. Additionally or alternatively, one or more of the

ridges

1208a, 1208b, 1208c, and 1208d can include an end surface 1208g that extends substantially parallel to the forward-facing surface 1204a and/or the rearward-facing surface 1204b of the support portion 1204. Surface 1208f may be flush with a radially outer circumferential surface of haptic 1206 and/or haptic 1204.

The ridge 1208a may extend over, along, or around the outer curvature of one of the haptics 1206 and may taper at or near the tip of that haptic 1206 (e.g., may taper downward in height). The tapered portion may define a first end of the ridge 1208 a. The ridge 1208a may have a second end opposite its first end. The second end may taper (e.g., may taper downward in height). The taper at the second end of the ridge 1208a may have a greater slope than the taper at the first end. The

ridges

1208b, 1208c, and 1208d may be similarly shaped.

91 between their tapered ends, the

ridges

1208a, 1208b, 1208c, and 1208d may have a height (measured in the anterior-posterior direction relative to the surface of the support portion 1204) such that the forward facing surface 1202b of the optic 1202 may extend forward of the ridge 1208a and/or the ridge 1208b, and/or the rearward facing surface 1202c of the optic 1202 may extend rearward of the ridge 1208c and/or the ridge 1208 d. It is also contemplated that one or more of the

ridges

1208a, 1208b, 1208c, 1208d can have a constant height between their tapered ends.

92 as best shown in fig. 12A, the

ridges

1208a and 1208b may be discrete ridges separated by gaps. Additionally or alternatively,

ridges

1208c and 1208d may be discrete ridges separated by gaps. For example, internal flexure of haptics 1206 may exclude ridges to allow radial compression of haptics 1206 toward optical portion 1202.

The ridge 1208a of 93 may include a first curved portion 1208h and a second curved portion 1208 i. From the perspective of the optical device 1202, the first curved portion 1208h and the second curved portion 1208i can be substantially concave. Where the first curved portion 1208h and the second curved portion 1208i meet, they may form a convex portion 1208j of the ridge 1208 a. The

ridges

1208b, 1208c, and/or 1208d may be similarly shaped.

94 one or more ridges 1208 may be arranged in pairs. For example, the

ridges

1208a, 1208b may form a first pair of front ridges and/or the

ridges

1208c, 1208d may form a second pair of rear ridges. With respect to the pair of

ridges

1208a and 1208b, end portions of one of the ridges may extend beyond opposite end portions of the other ridge and toward a middle portion of the other ridge. A similar arrangement may exist for a pair of

ridges

1208c and 1208 d.

Referring to fig. 13A-13C, various alternative

non-modular IOLs

1300A, 1300B and 1300C are shown in perspective view. For example, each IOL 1300 includes an optical portion 1302 that can be monofocal (fixed focal length), adaptive (variable focal length), toric, multifocal, or extended depth of focus modes. Each IOL 1300 also includes two or more haptics 1306 connected to optic portion 1302 via connecting arms 1312. In contrast to conventional IOLs in which the haptics are curved to provide a radial spring force in addition to contact with the lens capsule's inner equator, the webs 1312 provide a radial spring force independently of the haptics 1306, and the haptics 1306 may be rounded to maintain the same amount of contact area with the lens capsule's inner equator independently of radial compression of the webs 1312. This configuration provides more consistent stability to the IOL 1300 in the capsular bag regardless of the size of the capsular bag. For example, haptics 1306 may extend 60 ° to 90 °, 90 ° to 120 °, or 120 ° to 150 ° around the perimeter of optic 1302 and may have a constant radius of about 4.0 to 5.0 mm. For example, the connecting arm 1312 may be in the form of a multi-bar cantilever (zigzag) spring 1312A, a single-bar cantilever (curvilinear) spring 1312B, or a semi-elliptical spring 1312C.

96 the foregoing discussion of the present disclosure has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. While the present disclosure includes a description of one or more embodiments and certain variations and modifications, other variations and modifications are within the scope of the present disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

1. An intraocular lens system, comprising:

a. a base, the base comprising: an annular body having a central bore extending therethrough, the annular body comprising: a posterior protrusion extending around an inner circumference of the annular body, two slots extending from a front side of the annular body to the posterior protrusion, and two haptics extending radially outward from the annular body; and

b. a lens comprising an optic portion and two haptics extending radially outward from the optic portion, wherein the lens is disposed in the central bore of the annular body and rests on the anterior side of the protrusion, and wherein the haptics of the lens are disposed in the slots and extend radially outward from the annular body.

2. The intraocular lens system of claim 1 wherein two haptics of the lens extend from diametrically opposite sides of the optic portion.

3. An intraocular lens system as in claim 1 wherein said slots each have a posterior portion and an anterior portion.

4. An intraocular lens system as in claim 3 wherein the posterior portion has a width greater than the anterior portion.

5. An intraocular lens system as in claim 1 wherein said slots are each in the shape of an inverted T.

6. An intraocular lens system as in claim 1 wherein each haptic of the lens comprises a beveled portion connecting itself to the optic portion.

7. The intraocular lens system of claim 6 wherein the grooves each comprise a beveled portion configured to receive a haptic of the lens.

8. The intraocular lens system of claim 1, wherein the grooves are each configured to interlock with a haptic of the lens when the lens is rotated relative to the base.

9. An apparatus configured for insertion into an eye, the apparatus comprising:

a base, comprising:

a first portion comprising:

the first wall is provided with a first opening,

a first opening at a first end of the first wall,

a first cavity adjacent to the first opening, wherein a width of the first cavity is greater than a width of the first opening,

a second part, and

a middle portion extending between the first portion and the second portion, wherein the middle portion is wider than the first portion and the second portion, and the middle portion has a recess therein adjacent the first cavity,

wherein the recess is formed by a front protrusion, a rear protrusion, and a side wall extending in the front-rear direction.

10. The device of claim 9, wherein the first wall slopes radially inward, wherein a diameter of the first wall increases as the first opening approaches the intermediate portion.

11. The apparatus of claim 9, wherein the second portion comprises:

the second wall is provided with a plurality of holes,

a second opening at a second end of the second wall,

a second cavity adjacent to the second opening, wherein the second cavity has a diameter greater than a diameter of the second opening.

12. The device of claim 9, wherein a radial wall thickness of the intermediate portion is less than an axial height of the base portion.

13. The apparatus of claim 9, wherein the second portion comprises:

the second wall is provided with a plurality of holes,

a second opening at a second end of the second wall,

a second cavity adjacent to the second opening, wherein a width of the second cavity is greater than a width of the second opening, and wherein the recess and the second opening are separated by the second cavity.

14. The apparatus of claim 9, wherein the width of the first wall increases as the first wall approaches the intermediate portion.

15. The device of claim 9, further comprising a lens configured to be received in the recess.

16. An apparatus configured for insertion into an eye, the apparatus comprising:

a base, comprising:

a front housing portion having a front opening;

a rear housing portion having a rear opening;

an intermediate housing portion between the front housing portion and the rear housing portion, the intermediate housing portion having a recess, wherein the recess is formed by a front projection, a rear projection, and a side wall extending in a front-to-rear direction, and wherein the recess extends continuously along a circumference of the base; and

a channel extending through the front housing portion, the rear housing portion, and the intermediate housing portion; and

a lens configured to be received in the intermediate shell portion, the lens comprising:

a central optical element; and

a pair of tabs projecting radially outward from the central optical element, wherein the tabs are configured to mate with one or more surfaces of the intermediate housing portion.

17. The device of claim 16, wherein the pair of tabs comprises a first fixed tab and a second actuatable tab.

18. The device of claim 16, wherein the tabs extend from diametrically opposite locations of the central optical element.

19. The device of claim 16, wherein the recess is wider than the front housing portion and the rear housing portion.

20. The device of claim 16, wherein the outer diameter of the intermediate housing portion is about 8.5 mm.

21. The device of claim 16, wherein the inner diameter of the intermediate housing portion is about 7 mm.